Product |
component |
Method |
Validation of the the method |
SOP |
Product1 |
component1 |
Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component1 |
Single Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component2 |
Single Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component2 |
rinse sample |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component2 |
dissolution Test |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component3 |
Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component3 |
Single Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component3 |
Impurity |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product1 |
component3 |
dissolution Test |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component1 |
Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component1 |
Single Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component1 |
Impurity |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component1 |
swab sample |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component1 |
rinse sample |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component1 |
dissolution Test |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
Product2 |
component2 |
Assay |
System Suitability |
Specificity |
Forced Degradation |
Accuracy |
Linearity |
Precision1 |
Precision2 |
Ruggdness |
send if Ruggdness is passed |
I explain my interpretation:A Product can have one or more components
The components can be subjected to one or more test methods
each Method must undergo 8 Validations
the Ruggdness Validation decides whether to send it
now let's see the Validations:must occur in succession or you cannot switch from System Suitability to Specificity if System Suitability is not set to Done